Pharmaceutical process validation / edited by Robert A. Nash, Alfred H. Wachter.

Contributor(s): Berry, Ira R, 1942- | Nash, Robert A, 1930-Material type: Text

TextLanguage: English Series: Drugs and the pharmaceutical sciencesPublication details: New York : Marcel Dekker, c2003. Edition: International 3rd ed., rev. and expandedDescription: xxxvi, 860 p. : ill. ; 24 cmISBN: 0824708385 (alk. paper); 9780824708382Subject(s): Pharmaceutical industry -- Quality control | Drugs -- Standards -- United States | Drug Evaluation -- standards -- United States | Drug Industry -- standards -- United States | Quality ControlDDC classification: 615.1 LOC classification: RS189 | .P46 2003Online resources: Publisher description | WorldCat details | E-Book Fulltext

Contents:

TOC Regulatory basis for process validation -- Prospective process validation -- Retrospective validation -- Sterilization validation -- Validation of solid dosage forms -- Validation for medical devices -- Validation of biotechnology processes -- Transdermal process validation -- Validation of lyophilization -- Validation of inhalation aerosols -- Process validation of phamaceutical ingredients -- Qualification of water and air handling systems -- Equipment and facility qualification -- Validation and verification of cleaning processes -- Validation of analytical methods and processes -- Computer system validation: controlling the manufacturing process -- Integrated packaging validation -- Analysis of retrospective production data using quality control charts -- Statistical methods for uniformity and dissolution testing -- Change control and SUPAC -- Process validation and quality assurance -- Validation in contract manufacturing -- Terminology of nonaseptic proess validation -- Harmonization GMPs, and validation.

Summary: The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends

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Holdings
Item type	Current library	Collection	Call number	Copy number	Status	Barcode
E-Book	EWU Library E-book	Non-fiction	615.1 PHA 2003 (Browse shelf(Opens below))		Not for loan
Text	EWU Library Reserve Section	Non-fiction	615.1 PHA 2003 (Browse shelf(Opens below))	C-1	Not For Loan	16427
Text	EWU Library Reserve Section	Non-fiction	615.1 PHA 2003 (Browse shelf(Opens below))	C-2	Not For Loan	16428

Total holds: 0

Includes bibliographical references and index.

TOC Regulatory basis for process validation --
Prospective process validation --
Retrospective validation --
Sterilization validation --
Validation of solid dosage forms --
Validation for medical devices --
Validation of biotechnology processes --
Transdermal process validation --
Validation of lyophilization --
Validation of inhalation aerosols --
Process validation of phamaceutical ingredients --
Qualification of water and air handling systems --
Equipment and facility qualification --
Validation and verification of cleaning processes --
Validation of analytical methods and processes --
Computer system validation: controlling the manufacturing process --
Integrated packaging validation --
Analysis of retrospective production data using quality control charts --
Statistical methods for uniformity and dissolution testing --
Change control and SUPAC --
Process validation and quality assurance --
Validation in contract manufacturing --
Terminology of nonaseptic proess validation --
Harmonization GMPs, and validation.

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends

Pharmacy

Sagar Shahanawaz

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